MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX 180NRE DIALYZER FINISHED ASSY.; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 0500318E

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anemia (1706); Hemorrhage/Bleeding (1888); Thrombocytopenia (4431)

Event Date 06/24/2023

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: a temporal relationship exists between hd treatment utilizing the fresenius optiflux180nre dialyzer and the patient event of thrombocytopenia and anemia which resulted in blood transfusion.The actual sample of the optiflux 180nre dialyzer has reportedly been discarded and dialyzer will not be returned to the manufacturer for further analysis.There were no allegations of any visible defect with the fresenius dialyzers.The fresenius optiflux 180 nre dialyzer manufacturer instructions for use document that thrombocytopenia is a potential side effect that may occur (although rare) with use of the product of use.Moreover, systemic heparinization of the patient prior to initiating and during hemodialysis treatment is recommended to mitigate the formation of clots on the dialyzer fibers (standard of care).Anemia is a well-documented complication in patients with renal failure due to the disease process of this condition.Additionally, it was indicated that the patient was not receiving any anticoagulation during dialysis treatments and did have clot formation on dialyzer fibers.The patient¿s comorbid condition of renal failure coupled with incidence of clotted dialyzer fibers are likely contributing factors for the reported anemia.Furthermore, the fresenius optiflux 180 nre dialyzer membrane cannot be excluded as a causal factor in the patient¿s thrombocytopenia given this is a known potential side effect with use of the product.

Event Description

It was reported by a senior nurse manager (for acute dialysis services) that this hemodialysis (hd) patient was experiencing a drop in hematocrit, hemoglobin, and platelets.It was stated that active bleeding, disseminated intravascular coagulation (dic) and heparin-induced thrombocytopenia (hit) were ruled out by hematology / oncology.The senior nurse manager was inquiring whether fresenius produced a cellulose-based dialyzer as it was suspected that the polystyrene filters may be causing this issue.In additional follow-up, the senior nurse manager stated that on (b)(6) 2023 this patient was admitted to the hospital in the intensive care unit (icu) for acute renal failure.It was reported that on (b)(6) 2023 the patient was initiated on hemodialysis for renal replacement needs utilizing a new fresenius optiflux 180nre dialyzer for each treatment (lot numbers for each dialyzer in use are unknown).The nurse manager stated that the patient was not receiving heparin for dialysis treatments (standard of care to prevent clotting of the dialyzer membrane) and noted there was visible clotting on dialyzer fibers.During hospitalization, the patient developed thrombocytopenia and anemia which was characterized by a continued drop in platelets (from 204k on hospital admission to 29k on (b)(6) 2023) and hemoglobin (10.8 on hospital admission to 6.8 on (b)(6) 2023).As a result, on (b)(6) 2023 the patient received one unit of blood for anemia.Additionally, hematology/oncology service was consulted for this issue and it was recommended that the patient be switched to a cellulose based dialyzer as the fresenius optiflux 180nre dialyzer membrane is known to induce thrombocytopenia as a potential adverse effect.On (b)(6) 2023, the patient was switched to the baxter revaclear 400 dialyzer (as that was what was in stock at the hospital).The nurse manager stated the patient did not have any other untoward events when using the fresenius dialyzer.The patient remained hospitalized at the time follow-up was completed.It was stated the patient¿s hemoglobin and platelet counts have remained stable (9.0/ 149k respectively on (b)(6) 2023) and the patient has had no other reported issues.The nurse manager confirmed there were no visible defects in any of the fresenius optiflux 180 nre dialyzers used for the patient¿s hemodialysis treatment.Lot number (s) could not be provided.It was stated the dialyzers in use have been discarded and therefore are not available for return to the manufacturer for further analysis.

Manufacturer Narrative

Plant investigation: the complaint could not be confirmed as a definitive conclusion regarding the complaint incident cannot be reached with the information provided.A sample was not returned to the manufacturer which prevented a physical evaluation from being performed.A lot number was provided by the complainant and a facility id number was not available, an sap delivery search could not be performed to identify all lot numbers with the reported catalog number shipped to the complainant in the three months prior to the occurrence date.Therefore, a lot history review or production record review could not be performed.The optiflux dialyzer instruction for use indicates the following: ¿in rare cases, thrombocytopenia or hypersensitivity reactions including anaphylactic or anaphylactoid reactions to the dialyzer, or other elements in the extracorporeal circuit, may occur during hemodialysis.Hypersensitivity reactions may cause mild to severe signs and symptoms, including itching, flushing, hives, swelling, fever, leukopenia, hypotension, hypertension, shortness of breath with wheezing, arrhythmias, and/or respiratory arrest.Patients with a history of hypersensitivity reactions or patients who have a history of being highly sensitive and allergic to a variety of substances should be carefully monitored during treatment.¿.

Event Description

It was reported by a senior nurse manager (for acute dialysis services) that this hemodialysis (hd) patient was experiencing a drop in hematocrit, hemoglobin, and platelets.It was stated that active bleeding, disseminated intravascular coagulation (dic) and heparin-induced thrombocytopenia (hit) were ruled out by hematology/oncology.The senior nurse manager was inquiring whether fresenius produced a cellulose-based dialyzer as it was suspected that the polystyrene filters may be causing this issue.In additional follow-up, the senior nurse manager stated that on (b)(6) 2023, this patient was admitted to the hospital in the intensive care unit (icu) for acute renal failure.It was reported that on (b)(6) 2023, the patient was initiated on hemodialysis for renal replacement needs utilizing a new fresenius optiflux 180nre dialyzer for each treatment (lot numbers for each dialyzer in use are unknown).The nurse manager stated that the patient was not receiving heparin for dialysis treatments (standard of care to prevent clotting of the dialyzer membrane) and noted there was visible clotting on dialyzer fibers.During hospitalization, the patient developed thrombocytopenia and anemia which was characterized by a continued drop in platelets (from 204k on hospital admission to 29k on (b)(6) 2023) and hemoglobin (10.8 on hospital admission to 6.8 on (b)(6) 2023).As a result, on (b)(6) 2023, the patient received one unit of blood for anemia.Additionally, hematology/oncology service was consulted for this issue and it was recommended that the patient be switched to a cellulose based dialyzer as the fresenius optiflux 180nre dialyzer membrane is known to induce thrombocytopenia as a potential adverse effect.On (b)(6) 2023, the patient was switched to the baxter revaclear 400 dialyzer (as that was what was in stock at the hospital).The nurse manager stated the patient did not have any other untoward events when using the fresenius dialyzer.The patient remained hospitalized at the time follow-up was completed.It was stated the patient¿s hemoglobin and platelet counts have remained stable (9.0/ 149k respectively on (b)(6) 2023) and the patient has had no other reported issues.The nurse manager confirmed there were no visible defects in any of the fresenius optiflux 180 nre dialyzers used for the patient¿s hemodialysis treatment.Lot number (s) could not be provided.It was stated the dialyzers in use have been discarded and therefore are not available for return to the manufacturer for further analysis.

Manufacturer Narrative

Correction: h6 (health effect clinical code), g3 (date received).The date received on the initial submission of this mdr report was incorrectly stated as 6/30/2023.The correct date received is 6/23/2023.

Event Description

It was reported by a senior nurse manager (for acute dialysis services) that this hemodialysis (hd) patient was experiencing a drop in hematocrit, hemoglobin, and platelets.It was stated that active bleeding, disseminated intravascular coagulation (dic) and heparin-induced thrombocytopenia (hit) were ruled out by hematology/oncology.The senior nurse manager was inquiring whether fresenius produced a cellulose-based dialyzer as it was suspected that the polystyrene filters may be causing this issue.In additional follow-up, the senior nurse manager stated that on (b)(6) 2023, this patient was admitted to the hospital in the intensive care unit (icu) for acute renal failure.It was reported that on (b)(6) 2023, the patient was initiated on hemodialysis for renal replacement needs utilizing a new fresenius optiflux 180nre dialyzer for each treatment (lot numbers for each dialyzer in use are unknown).The nurse manager stated that the patient was not receiving heparin for dialysis treatments (standard of care to prevent clotting of the dialyzer membrane) and noted there was visible clotting on dialyzer fibers.During hospitalization, the patient developed thrombocytopenia and anemia which was characterized by a continued drop in platelets (from 204k on hospital admission to 29k on (b)(6) 2023) and hemoglobin (10.8 on hospital admission to 6.8 on (b)(6) 2023).As a result, on (b)(6) 2023, the patient received one unit of blood for anemia.Additionally, hematology/oncology service was consulted for this issue and it was recommended that the patient be switched to a cellulose based dialyzer as the fresenius optiflux 180nre dialyzer membrane is known to induce thrombocytopenia as a potential adverse effect.On (b)(6) 2023, the patient was switched to the baxter revaclear 400 dialyzer (as that was what was in stock at the hospital).The nurse manager stated the patient did not have any other untoward events when using the fresenius dialyzer.The patient remained hospitalized at the time follow-up was completed.It was stated the patient¿s hemoglobin and platelet counts have remained stable (9.0/ 149k respectively on (b)(6) 2023) and the patient has had no other reported issues.The nurse manager confirmed there were no visible defects in any of the fresenius optiflux 180 nre dialyzers used for the patient¿s hemodialysis treatment.Lot number (s) could not be provided.It was stated the dialyzers in use have been discarded and therefore are not available for return to the manufacturer for further analysis.

• Brand Name: OPTIFLUX 180NRE DIALYZER FINISHED ASSY.
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): OGDEN MANUFACTURING PLANT; director, site quality; 475 west 13th street; ogden UT 84404
• Manufacturer (Section G): OGDEN MANUFACTURING PLANT; director, site quality; 475 west 13th street; ogden UT 84404
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 17316844
• MDR Text Key: 319178645
• Report Number: 0001713747-2023-00454
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100156
• UDI-Public: 00840861100156
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162488
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 07/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 0500318E
• Device Catalogue Number: 0500318E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 06/30/2023
• Initial Date FDA Received: 07/13/2023
• Supplement Dates Manufacturer Received: 07/24/2023; 07/25/2023
• Supplement Dates FDA Received: 07/24/2023; 07/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 101 KG